Contact number:
18127041985
News Detail

"Medical Device Clinical Trial Quality Management Standards" Implemented in June

Issuing time:2020-06-01 11:32

In order to strengthen the management of clinical trials of medical devices, safeguard the rights and interests of subjects in the clinical trials of medical devices, and ensure the standardization of clinical trials of medical devices, the results are true, scientific, reliable and traceable. According to the Regulations on the Supervision and Administration of Medical Devices, food and drugs The General Administration of Supervision, together with the National Health and Family Planning Commission, formulated and promulgated the "Quality Management Standards for Medical Device Clinical Trials" (hereinafter referred to as the "Code"), which will be implemented on June 1, 2016.


For the first time, the "Specification" stipulates that the drug regulatory department at or above the provincial level is responsible for the supervision and management of clinical trials of medical devices, and conducts verification against serious or repeated clinical trial program deviations and suspected fraud. Industry insiders pointed out that the introduction of the "standard" indicates that following the storm of drug clinical trial data verification, the medical device field will usher in a storm of clinical data verification this year.

Share to:
Contact us

Tel:

18127041985


E-mail:

chenjiajian@xinruimed.com


Address:

Yuanhui Road, Chenjiang Street, Zhongkai High-tech Zone, Huizhou City   No. 8-1, (plant 2) A3 plant, 2nd floor

NAVIGATION
About us                   ProductCenter
Manufacturing          Solution
News                       Contact us
CONTACT US
Address: No. 8-1, Yuanhui Road, Chenjiang Street, Zhongkai High-tech District, Huizhou City,
(Plant 2) 2nd Floor of A3 Plant
Tel:18127041985
E-mail:chenjiajian@xinruimed.com
Scan WeChat QR code
CASE NUMBER
Copyright 2020 © Huizhou Xinrui Medical Technology Co., Ltd.